MAUDE Adverse Event Report: MAQUET SAS POWERLED II; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD569202911

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On 8th september, 2020 getinge became aware of an issue with powerled ii surgical light.As it was stated, the customer complained about the heat generated by the operating theater light.There was no injury reported however we decided to report the issue in abundance of caution as heat generated by light head may cause serious injury.

Manufacturer Narrative

Getinge became aware of an issue with powerled ii surgical light.As it was stated, the customer complained about the heat generated by the operating theater light.There was no injury reported however, we decided to report the issue in abundance of caution as heat generated by light head may cause serious injury.During investigation, it was revealed that device was working according to the manufacturer¿s specification as no actual technical failure occurred.In the time when the event occurred, the device was not being used for patient treatment and it contributed to incident.When reviewing similar reportable events for the same device, we have been able to confirm that the investigated issue has never led to serious injury or worse.The tests carried out during the design and the development of powerled ii show that the thermal measurements of the housing, the irradiance measurement, the illuminance measurement and uv measurements indicate values in accordance with the standard iec 60601.At a distance of 1 000 mm, for a single light head: - the illuminance of a single surgical light must reach the minimum value of 40 000 lx and must not exceed 160 000 lx.- the total irradiance of the illuminated area shall not exceed 1 000 w/m².The powerled ii irradiance is inferior to 500 w/m² in nominal mode.- the uv radiation for wavelengths below 400 nm shall not exceed 10 w/m².The powerled ii uv percentage corresponds to 0,01 w/m².The optical tests performed on the production line for all light heads manufactured ensure that the products are in conformity with the technical specifications.The powerled ii instruction for use ifu 01811 mentions two warnings related to this event.To prevent any incident the instruction for use mentions that the light is a form of energy that can cause tissue to dry, particularly if lightbeams from more than one lighthead are superimposed.The user must be aware of the risks relating to exposure of open wounds to a light source of too great an intensity.The user must be vigilant and must adjust the level of illumination to suit the patient concerned and to avoid undesirable temperature increases in the operating field, particularly during a lengthy procedure.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: POWERLED II
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10519760
• MDR Text Key: 206764164
• Report Number: 9710055-2020-00363
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD569202911
• Device Catalogue Number: ARD569202911
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1